[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Notices]
[Pages 34388-34389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14003]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2011-E-0133; FDA-2011-E-0136]
Determination of Regulatory Review Period for Purposes of Patent
Extension; CYSVIEW (Previously HEXVIX)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for CYSVIEW (previously HEXVIX) and is
publishing this notice of that determination as required by law. FDA
has made the determination because of the submission of applications to
the Director of Patents and Trademarks, Department of Commerce, for the
extension of a patent which claims that human drug product.
ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6284, Silver Spring, MD 20993-0002, 301-796-3602.
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of the application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA recently approved for marketing the human drug product CYSVIEW
(hexaminolevulinate hydrochloride). CYSVIEW is an optical imaging agent
indicated for use in the cystoscopic detection of non-muscle invasive
papillary cancer of the bladder among patients suspected or known to
have lesion(s) on the basis of a prior cystoscopy. Subsequent to this
approval, the Patent and Trademark Office received patent term
restoration applications for CYSVIEW (U.S. Patent Nos. 7,247,655 and
7,348,361) from Photocure ASA, and the Patent and Trademark Office
requested FDA's assistance in determining the patents' eligibilities
for patent term restoration. In a letter dated June 9, 2011, FDA
advised the Patent and Trademark Office that this human drug product
had undergone a regulatory review period and that the approval of
CYSVIEW represented the first permitted commercial marketing or use of
the product. Thereafter, the Patent and Trademark Office requested that
FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for
CYSVIEW is 3,103 days. Of this time, 2,770 days occurred during the
testing phase of the regulatory review period, while 333 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: November 30, 2001. The applicant claims October 29, 2001, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was November 30, 2001, which was 30 days after FDA receipt of the IND.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: June 30,
2009. FDA has verified the applicant's claim that the new drug
application (NDA) for CYSVIEW (NDA 22-555) was submitted on June 30,
2009.
3. The date the application was approved: May 28, 2010. FDA has
verified the applicant's claim that NDA 22-555 was approved on May 28,
2010.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks 686 days or 564
days, respectively, of patent term extension.
Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by August 10, 2012. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
[[Page 34389]]
period by December 10, 2012. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document.
Comments and petitions that have not been made publicly available
on http://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 29, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-14003 Filed 6-8-12; 8:45 am]
BILLING CODE 4160-01-P